Fludroxycortide API Manufacturer in India

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Fludroxycortide API

Fludroxycortide, also known as Flurandrenolide or Flurandrenolone, is a synthetic fluorinated corticosteroid used primarily as a topical anti-inflammatory medicine for various inflammatory and pruritic skin disorders. It is associated with topical products including creams, ointments and medicated adhesive tapes.

Fludroxycortide has the molecular formula C₂₄H₃₃FO₆, molecular weight 436.50 g/mol, and CAS Registry Number 1524-88-5. PubChem identifies the compound as CID 15209 and gives the FDA UNII as 8EUL29XUQT.

Chemical Identity

The systematic chemical name is:

6-Fluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis(oxy)]-(6α,11β,16α)-pregn-4-ene-3,20-dione

Fludroxycortide contains a corticosteroid nucleus with a fluorine substituent and a 16,17-acetonide structure.

Key Features

  • Product Name: Fludroxycortide
  • USAN Name: Flurandrenolide
  • Other Name: Flurandrenolone
  • CAS Number: 1524-88-5
  • PubChem CID: 15209
  • Molecular Formula: C₂₄H₃₃FO₆
  • Molecular Weight: 436.50 g/mol
  • UNII: 8EUL29XUQT
  • DrugBank ID: DB00846
  • Chemical Class: Synthetic Corticosteroid
  • Pharmacological Class: Topical Glucocorticoid
  • ATC Code: D07AC07
  • Route: Topical 

Pharmaceutical Application

Fludroxycortide is used topically for the treatment of inflammatory skin conditions. It is available in different topical formulations, including cream, ointment and medicated adhesive tape.

Mechanism of Action

Fludroxycortide acts as a corticosteroid receptor agonist. Topical corticosteroids reduce inflammatory responses in the skin and provide anti-inflammatory and antipruritic effects.

Pharmaceutical Forms

Fludroxycortide has been marketed in topical formulations including:

  • Cream
  • Ointment
  • Medicated adhesive tape

Products associated with the substance include Cordran and Haelan.

Quality & Analytical Characteristics

Fludroxycortide is a defined chemical substance with established structural identifiers. For pharmaceutical-grade material, identity, assay, related substances, residual solvents, water content and other applicable quality attributes should be controlled according to the current applicable pharmacopoeial or approved product specification.

I have not inserted unsupported numerical limits for individual QC tests where an authoritative current numerical specification could not be verified.

Storage & Handling

Fludroxycortide API should be stored in a suitable, tightly closed pharmaceutical container under the conditions specified by the applicable approved specification. Handling should follow appropriate pharmaceutical occupational-safety procedures.

Detailed Specifications

Parameter Specification
Appearance White to off-white crystalline powder
Identification IR & HPLC compliant
Loss on Drying NMT 1.0%
Residue on Ignition NMT 0.5%
Heavy Metals NMT 10 ppm
pH (1% Solution) 2.0 – 3.0
Individual Impurity NMT 0.5%
Total Impurities NMT 1.0%
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